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Not yet recruiting NCT06822023

Virtual Reality and Its Use in Reducing Perioperative Stress in Cataract Surgery

No phase Interventional Virtual Reality Eye Disease Cataract Surgery Anesthesia Cataract Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: virtual reality mask.
Who it may be relevant to
Registry conditions: Virtual Reality, Eye Disease, Cataract Surgery Anesthesia, Cataract Surgery. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This project is to evaluate the benefits of utilising virtual reality (VR) headsets with the aim of reducing peri-operative anxiety in cataract surgery and hence reducing the need for sedation in patients with significant stress levels noted during preassessment. This is a novel study, and with the increased use of VR technology throughout medicine, we may be able to offer our patients alternative management modalities to reduce stress and reduce need for medications with their subsequent potential side effects. It may also improve the quality of care provided and patients' experience with the cataract extraction procedure and might reduce the social care burden associated with standard sedation procedures. All patients will need to fill a quick preoperative anxiety and information scale questionnaire to assess their level of anxiety utilising The Amsterdam Preoperative Anxiety and Information Score. Patients will be randomised into 2 groups: 1. Conventional group: patients will be prepared as per the standard routine clinical and further explanation of the procedure will be given. Before proceeding to the anaesthetic room, the patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out. 2. Interventional Group: patients will be prepared as per the standard routine clinical care; they will then be wearing the VR mask for 10 minutes. Before proceeding to the anaesthetic room, patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out. Post operation, a record will be taken of the surgeon's decision on whether they want the second eye cataract surgery to be done under sedation (this is already standard practice at our centre). Finally, the patient will be asked to fill in one final grading score on whether they are happy with their decision to take/not take sedation.

Interventions

  • Device virtual reality mask
    Patients will be prepared as per the standard routine clinical care; they will then be wearing the VR mask for 10 minutes. No other study have looked into VR mask prior to cataract surgery

Primary outcome measures

  • Anxiety score [Time frame: 10 mins following intervention]
Secondary outcome measures (2)
  • Patient required sedation after intervention [Time frame: 10 mins]
  • Patient required sedation for second eye surgery [Time frame: Following surgery, approximately 30-60 mins following intervention]

Eligibility criteria

Inclusion criteria

  • Patients listed for cataract surgery under local anaesthetic (topical or regional) with sedation planned.
  • First eye cataract procedures will only be included.
  • Capacity to give informed consent, cognitive and linguistic ability sufficient to understand and fill out questionnaire

Exclusion criteria

  • Epilepsy
  • severe vertigo
  • poor visual acuity (below 6/60 best corrected in the best seeing eye)
  • significant hearing impairment
  • recent facial injury/burn.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Jacobi PC, Dietlein TS, Jacobi FK. A comparative study of topical vs retrobulbar anesthesia in complicated cataract surgery. Arch Ophthalmol. 2000 Aug;118(8):1037-43. doi: 10.1001/archopht.118.8.1037. PMID 10922195

Identifiers

NCT: NCT06822023 · 23/WS/0110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗